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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device scalpel, one-piece
Regulation Description Manual surgical instrument for general use.
Product CodeGDX
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 21 21
2022 5 5
2023 5 5
2024 3 3
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Remove Packaging Material 7 7
Mechanical Problem 5 5
Break 3 3
Unsealed Device Packaging 3 3
Tear, Rip or Hole in Device Packaging 3 3
Detachment of Device or Device Component 3 3
Device Contaminated During Manufacture or Shipping 2 2
Degraded 2 2
Contamination /Decontamination Problem 1 1
Unintended Ejection 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Delivered as Unsterile Product 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Nonstandard Device 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
Laceration(s) 6 6
Necrosis 1 1
Insufficient Information 1 1
Hemorrhage/Bleeding 1 1

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